The Reality of Regulatory Affairs Today
Regulatory submissions demand precision, consistency, and alignment with authority-specific requirements. Traditional document production processes create gaps between underlying analysis and final documentation, leading to queries, delays, and avoidable deficiency letters.
Document-Analysis Disconnect
Regulatory documents written separately from underlying analysis, creating inconsistency and regulatory queries. When medical writers work from summary tables rather than source data, critical nuances get lost and inconsistencies emerge across documents.
Multi-Authority Formatting
FDA structured BRA, EMA RMP, PMDA J-RMP each have different requirements. Manual reformatting is error-prone and time-consuming. The same core benefit-risk analysis must be repackaged three different ways, creating redundant work and version control nightmares.
Compressed Timelines
Filing deadlines create document production pressure that compromises thoroughness and increases risk of deficiency letters. When you're racing against submission dates, comprehensive quality review becomes a luxury you can't afford.
Your Workflow, Transformed
Comprehensive Evidence Base with Full Provenance
Build your regulatory submission on a foundation of integrated, provenance-tracked data. Every statement in your documents links directly to source evidence, eliminating the disconnect between analysis and documentation that triggers regulatory queries.
- Multi-source data integration across clinical trials, post-marketing surveillance, literature, and real-world evidence
- Full provenance tracking from raw data through analysis to final document statements
- Automated evidence table generation with source citations for every data point
- Cross-reference validation ensuring consistency across all submission documents
Structured BRA Aligned with Regulatory Frameworks
Implement FDA's BRAT framework, EMA's benefit-risk methodology, and PMDA's requirements within a single analytical environment. Your benefit-risk assessment is structured from the start to meet authority expectations, not retrofitted during document production.
- BRAT framework implementation with effects tables and value trees formatted for FDA advisory committee review
- Quantitative benefit-risk methods (MCDA, stochastic simulation, PrOACT-URL) aligned with EMA guidance
- Scenario analysis and sensitivity testing to address potential regulatory questions proactively
- Subpopulation benefit-risk characterization for labeling discussions and risk minimization planning
Multi-Authority Document Generation
From a single benefit-risk analysis, generate CTD Module 2.5, EMA RMP, PMDA J-RMP, and advisory committee presentations—all formatted to authority-specific requirements. What used to require separate medical writing projects now happens automatically with full consistency.
- CTD Module 2.5 (Clinical Overview, Section 2.5.6) generated from quantitative benefit-risk framework
- Risk Management Plan aligned with EMA GVP Module V requirements, including safety specification and risk minimization measures
- Multi-authority formatting for FDA (eCTD), EMA (NeeS), and PMDA (CDISC) with automatic cross-reference validation
- Advisory committee presentation slides with effects tables, forest plots, and benefit-risk visualizations
Impact for Regulatory Affairs Teams
"ArcaScience transformed our regulatory submission process by eliminating the disconnect between analysis and documentation. Our CTD 2.5 and RMP are now generated directly from the quantitative benefit-risk assessment, with full provenance from raw data to final document statements. We've had zero inconsistency-related queries across our last six submissions to FDA, EMA, and PMDA."
Novartis Oncology: Accelerating Multi-Authority BLA Submission
Novartis Oncology used ArcaScience to prepare simultaneous FDA BLA, EMA MAA, and PMDA J-NDA submissions for a novel targeted therapy. By generating authority-specific documents from a single quantitative benefit-risk framework, they reduced document production time by 60% and achieved first-cycle approval from all three authorities.
Deepen Your Understanding
Implementing FDA's BRAT Framework: From Guidance to Practice
A practical guide to structured benefit-risk assessment aligned with FDA's BRAT framework for regulatory submissions.
Download →Multi-Authority Submissions: One Analysis, Three Formats
How leading pharma companies generate FDA, EMA, and PMDA submissions from a single benefit-risk framework.
Read →CTD 2.5 Excellence: Advisory Committee Presentations That Win Approval
Best practices for benefit-risk documentation that addresses regulatory concerns proactively.
Watch →